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Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients

Primary Purpose

Hepatitis B, Chronic

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EntecaBell ODT. 0.5mg
Baraclude Tab. 0.5mg
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Entecavir, EntecaBell ODT., Hepatitis B

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Over the age of 20 years old
  2. Patients with Chronic Hepatitis B diagnosed
  3. Patients who show positive HBsAg
  4. Patients who show positive HBeAg or negative HBeAg
  5. Patients who showed HBV DNA undetected(less than 300 copies/mL)
  6. Patients who have administered Baraclude Tab. 0.5mg for 1~4 years
  7. Patients who showed ALT less than 5 times of the upper limit in the normal range
  8. Patient who decided to participate and signed on an informed consent form willingly

Exclusion Criteria:

  1. Patients who have hepatitis C (HCV), hepatitis D (HDV), or human immunodeficiency virus (HIV)

  2. Patients with a uncompensated liver disease who have at least one of the following values or signs

    • Total bilirubin > 2.5mg/dl
    • Prothrombin time delayed more than three seconds of upper limit in the normal range
    • Serum Albumin < 3 g/dL
    • A medical history of ascites, jaundice, hemorrhage by varix, hepatic encephalopathy, or other signs of liver function loss
  3. Patients who are estimated to have hepatocellular carcinoma (HCC) through imaging examination or showed alpha-fetoprotein(AFP) more than 100 ng/mL
  4. Patients who showed Creatinine Clearance < 50 mL/min by calculating Cockcroft-Gault equation
  5. Patients who were not administered any anti-viral agents except Baraclude Tab.(Entecavir)
  6. Administration of other Investigational Product within 30 days
  7. History of malignant tumor within 5 years (including leukemia and lymphoma)
  8. Patients who have a severe disease, such as heart failure, renal failure, and pancreatitis, decided by an investigator to have an effect on this clinical trial
  9. Patients who have other hepatic diseases except hepatitis B
  10. Administration immunosuppressants or corticosteroids over 2 weeks within 24 weeks
  11. Patients who have to administer immunosuppressants or Nephrotoxic drugs, Hepatotoxic drugs for period of Clinical Trial
  12. Pregnant, breast-feeding and childbearing age who don't use adequate contraception
  13. Patients who are possible to decline daily function due to a mental disease or patients who are not able to understand the purpose and methods of this clinical trial
  14. Patients who received an organ transplant or are going to received an organ transplant
  15. Severe hypersensitivity to Entecavir
  16. Another clinical condition in investigator's judgement

Sites / Locations

  • Konkuk University Chungju Hospital
  • Dankook University Hospital
  • Chungnam National University Hospital
  • Kyungpook National University Hospital
  • Hanyang University Guri Hospital
  • Yeungnam University Hospital
  • Jeju National University Hospital
  • Chonbuk National University Hospital
  • Chonnam National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EntecaBell ODT.

Baraclude Tab.

Arm Description

Outcomes

Primary Outcome Measures

The rate of subjects who showed HBV DNA undetected (less than 300copies/mL)

Secondary Outcome Measures

The rate of subjects who showed HBV DNA undetected (less than 300copies/mL)
The Difference between the baseline and at the 24, 48 week of HBV DNA level(log10)
The rate of subjects who showed HBeAg serum loss
The rate of subjects who showed HBeAg seroconversion
The rate of subjects who showed HBsAg serum loss
The rate of subjects who showed HBsAg seroconversion
The rate of subjects who showed Virologic breakthrough

Full Information

First Posted
October 27, 2015
Last Updated
December 12, 2016
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT02588937
Brief Title
Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the antiviral activity and safety of EntecaBell ODT. in chronic hepatitis B Patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
Keywords
Entecavir, EntecaBell ODT., Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EntecaBell ODT.
Arm Type
Experimental
Arm Title
Baraclude Tab.
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
EntecaBell ODT. 0.5mg
Intervention Type
Drug
Intervention Name(s)
Baraclude Tab. 0.5mg
Primary Outcome Measure Information:
Title
The rate of subjects who showed HBV DNA undetected (less than 300copies/mL)
Time Frame
48 week
Secondary Outcome Measure Information:
Title
The rate of subjects who showed HBV DNA undetected (less than 300copies/mL)
Time Frame
24 week
Title
The Difference between the baseline and at the 24, 48 week of HBV DNA level(log10)
Time Frame
24, 48 week
Title
The rate of subjects who showed HBeAg serum loss
Time Frame
24, 48 week
Title
The rate of subjects who showed HBeAg seroconversion
Time Frame
24, 48 week
Title
The rate of subjects who showed HBsAg serum loss
Time Frame
48 week
Title
The rate of subjects who showed HBsAg seroconversion
Time Frame
48 week
Title
The rate of subjects who showed Virologic breakthrough
Time Frame
12, 24, 48 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over the age of 20 years old Patients with Chronic Hepatitis B diagnosed Patients who show positive HBsAg Patients who show positive HBeAg or negative HBeAg Patients who showed HBV DNA undetected(less than 300 copies/mL) Patients who have administered Baraclude Tab. 0.5mg for 1~4 years Patients who showed ALT less than 5 times of the upper limit in the normal range Patient who decided to participate and signed on an informed consent form willingly Exclusion Criteria: Patients who have hepatitis C (HCV), hepatitis D (HDV), or human immunodeficiency virus (HIV) Patients with a uncompensated liver disease who have at least one of the following values or signs Total bilirubin > 2.5mg/dl Prothrombin time delayed more than three seconds of upper limit in the normal range Serum Albumin < 3 g/dL A medical history of ascites, jaundice, hemorrhage by varix, hepatic encephalopathy, or other signs of liver function loss Patients who are estimated to have hepatocellular carcinoma (HCC) through imaging examination or showed alpha-fetoprotein(AFP) more than 100 ng/mL Patients who showed Creatinine Clearance < 50 mL/min by calculating Cockcroft-Gault equation Patients who were not administered any anti-viral agents except Baraclude Tab.(Entecavir) Administration of other Investigational Product within 30 days History of malignant tumor within 5 years (including leukemia and lymphoma) Patients who have a severe disease, such as heart failure, renal failure, and pancreatitis, decided by an investigator to have an effect on this clinical trial Patients who have other hepatic diseases except hepatitis B Administration immunosuppressants or corticosteroids over 2 weeks within 24 weeks Patients who have to administer immunosuppressants or Nephrotoxic drugs, Hepatotoxic drugs for period of Clinical Trial Pregnant, breast-feeding and childbearing age who don't use adequate contraception Patients who are possible to decline daily function due to a mental disease or patients who are not able to understand the purpose and methods of this clinical trial Patients who received an organ transplant or are going to received an organ transplant Severe hypersensitivity to Entecavir Another clinical condition in investigator's judgement
Facility Information:
Facility Name
Konkuk University Chungju Hospital
City
Chungju
State/Province
Chungcheongbuk-do
Country
Korea, Republic of
Facility Name
Dankook University Hospital
City
Cheonan
State/Province
ChungCheongnam-do
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
State/Province
Chungcheongnam-do
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
State/Province
Gyeong sangbuk-do
Country
Korea, Republic of
Facility Name
Hanyang University Guri Hospital
City
Guri
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital
City
Daegu
State/Province
Gyeongsangbuk-do
Country
Korea, Republic of
Facility Name
Jeju National University Hospital
City
Jeju
State/Province
Jeju-do
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
State/Province
Jeollanam-do
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients

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